FDA Hopes to Up Effectiveness of REMS

The FDA introduced its Risk Evaluation and Mitigation Strategies (REMS) into the healthcare system in 2007 in an effort to protect patients from potentially dangerous drugs. Now, the FDA hopes to better standardize and integrate REMS through 4 pilot programs.

The 4 projects concentrate on providing information to patients, educating providers, integrating documentation, and building a REMS information repository. These projects will potentially fix the problems manufacturers of medications have complained about since REMS inception, such as high cost and the inefficiency of creating a REMS plan.